NCT07530640

Brief Summary

The goal of this observational study is to learn about the safety and effects of atorvastatin in treatment of Chinese Kawasaki disease (KD) children complicated with coronary artery abnormalities (CAA) in acute phase. The main questions it aims to answer are: Is atorvastatin safe in Chinese children of acute KD? Does atorvastatin contribute to control the acute inflammation in KD and improve the CAA?

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
17mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Sep 2027

First Submitted

Initial submission to the registry

March 24, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

March 30, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

March 24, 2026

Last Update Submit

April 8, 2026

Conditions

Kawasaki DiseaseCoronary Artery Abnormalities

Keywords

Kawasaki DiseaseCoronary artery abnormalitiesAtorvastatinAcute

Outcome Measures

Primary Outcomes (1)

  • Incidence of statin-associated side effects in Chinese acute KD children with CAA

    Safety evaluation of atorvastatin in acute KD children, referring to the incidence of statin-associated side effects (SASE). SASE include statin-associated clinical adverse events, elevated transaminase, creatine kinase, blood glucose and hypocholesterolemia.

    Before, 2 weeks and 6 weeks after taking atorvastatin

Secondary Outcomes (8)

  • Change of levels of high-sensitivity C reactive protein (sCRP)

    Before, 1 week, 2 weeks and 6 weeks after taking atorvastatin

  • Change of levels of serum amyloid A(SAA)

    Before, 1 week, 2 weeks and 6 weeks after taking atorvastatin

  • Change of levels of interleukin-6 (IL-6)

    Before, 1 week, 2 weeks and 6 weeks after taking atorvastatin

  • Change of levels of NT-proBNP

    Before, 2 weeks and 6 weeks after taking atorvastatin

  • Change of levels of albumin

    Before, 1 week, 2 weeks and 6 weeks after taking atorvastatin

  • +3 more secondary outcomes

Interventions

Atorvastatin-acute KD with CAADRUG

The study is to be designed as dose-escalation protocol and enroll a minimum of 3 subjects per dose level (level 1, 0.15 mg/kg/day; level 2, 0.25 mg/kg/day; level 3, 0.4 mg/kg/day). Participants will take atorvastatin for 6 weeks. The numbers of dose-limiting toxicities (DLTs) are used to determine the maximum tolerated dose (MTD).

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Acute KD children complicated with CAA admitted to Cardiology ward in Children's Hospital of Fudan University, Shanghai, China

You may qualify if:

  • KD complicated with CAA, less than 20 days after the onset of KD, or more than 20 days after onset but the KD inflammation has not been controled.
  • IVIG and/or other anti-inflammatory treatments have been used/are being used.
  • The guardians agree to atorvastatin treatment and sign the informed consent form.

You may not qualify if:

  • Patients with history of family hypercholesterolemia/taking statins/severe chronic diseases.
  • Patients with abnormal laboratory data including CK≥500U/L, total cholesterol\<3.1mmol/L, ALT or AST≥ 2 times the upper limit of normal.
  • The guardians do not agree to atorvastatin treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, 201102, China

Location

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Condition Hierarchy (Ancestors)

VasculitisVascular DiseasesCardiovascular DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Fang Liu, MD

    Children's Hospital of Fudan University

    STUDY DIRECTOR

Central Study Contacts

Chen Chu, MD

CONTACT

+86 21 64932026chickenchu@163.com

Fang Liu, MD

CONTACT

+86 21 64932800liufang@fudan.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2026

First Posted

April 15, 2026

Study Start

March 30, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)